MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for PRUITT F3 CAROTID SHUNT E2012-10 manufactured by Lemaitre Vascular, Inc..
[181166338]
Elderly male with left carotid stenosis admitted for left carotid endarterectomy. During the surgery, shunt in patient, it was identified that it was not working properly. When the device was removed, it was evidenced that there was a hole in the tubing for the balloon for the proximal portion of the shunt. Device removed without difficulty and no known harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9763971 |
| MDR Report Key | 9763971 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-18 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRUITT F3 CAROTID SHUNT |
| Generic Name | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY |
| Product Code | MJN |
| Date Received | 2020-02-27 |
| Model Number | E2012-10 |
| Catalog Number | E2012-10 |
| Lot Number | PFT3595 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |